Surgical dispenser



' June 25, 1963 s. L. STACY ETAL SURGICAL DISPENSER Filed Dec. 29, 1961 M 3 5 Z T wm I ip W 7 3 M... W0. 4 4M W W... Z

INVENTORSJ V 3,095,159 Patented June 25, 1963 ice 3,095,159 SURGICAL DISPENSER Stanley Leroy Stacy, Somerville, NJ., and Francis Arthur Tanner, Jr., Wayland, Mass, assigiors to Ethicon, Inc., a corporation of New Jersey Filed Dec. 29, 1961, Ser. No. 163,139 Claims. (Cl, 24296) The present invention relates to dispensers, or holders, for surgical ligatures, more particularly to such dispensers on which a ligature is adapted to be wound for storage and dispensing in a sterile condition.

Ligatures, i.e., surgical strands of an absorbable material commonly used for tieing oil blood vessels to prevent bleeding during surgery, are supplied to hospitals in various lengths, most commonly and most conveniently for the hospitals, in single strands approximately 60" long.

Heretofore, such ligatures have been wound on a creel or coiled in a sleeve and wrapped in a sterile package in a way which normally results in kinks being formed in the ligature. The long lengths generally, either are coiled in the package, or Wound tightly on a creel in the form of a small diameter cylindrical rod. If the long length is first coiled, it is removed entirely by the sterile nurse and wound upon a small diameter glass rod or tube or around a piece of gauze, or the like, from which it may be unreeled for use. If the ligature is packaged on a creel, the whole creel is removed from the package prior to use. During use, the surgeon holds the ligature and runs it through his fingers to guide and grip it during tieing and cutting and to position it for the next tie. This continues for the longer ligatures for a serie of successive ligations, normally 12 or more for a 60" ligature, for example.

There are many disadvantages to the above procedures. First of all, the whole ligature is removed from its package prior to use and exposed to mechanical damage and direct contact contamination, such as may occur even in the sterile area. When long lengths are rewound on rods as described above, they must be wound tightly to prevent them from slipping off the rod. The l-igatures are often damaged during this operation from excessive tensions applied thereto and abrasion during winding. On the other hand, when the ligature is wound upon a small diameter cylindrical creel, it becomes very kinky and hard to handle when unwound by the nurse or the surgeon and must be stretched somewhat by hand to straighten it out. Stretching in this way also is apt to cause mechanical damage and direct contact contamination. Since the ligature is run through the surgeons fingers during use and gripped by the fingers during cutting, it again is exposed to mechanical damage which may cause the ligature, itself, to fray, and since it is not protected in any way but instead is held in the surgeons gloved hand, it also is again exposed to the possibility of direct contact contamination.

In ligating, as described above, the surgeon is required not only to tie oil the blood vessels and cut the ligature, but he also must grip and hold the remaining length of ligature each time he makes a tie or a cut. Often, this means that the yet unused portion of the ligature merely drags over the patient while the surgeon busies himself with tieing and cutting. This is a highly undesirable technique both from the standpoint of mechanical damage and of contamination.

In accordance with the present invention, a sterile ligature dispenser is provided which, prior to use, holds the ligature completely protected against both mechanical damage and direct contact contamination, yet in unkinked condition and completely ready for use. During use, that portion of the ligature which is not actually being used at the time to make a tie, remains protected against any mechanical damage or direct contamination. The length of ligature needed for a particular tie is dispensed easily and the ligature is held during tieing and cutting simply by cupping the dispenser in the palm of one hand thereby leaving the surgeon's fingers completely free to tie and cut.

The present invention contemplates a sterile dispenser for ligatures which comprises a reel for holding the ligature wound thereon, a circular supporting disc at one side of said reel, and a centrally located cylindrical boss extending sideways from said disc for supporting the reel from the disc. The supporting disc possesses an annular peripheral portion which extends radially beyond the periphery of the reel, and preferably axially over the reel on at least one side of the reel, for shielding the reel during dispensing. During ligating, the dispenser is cupped in the palm of one of the hands of the surgeon where it is held by the pressure ofportions of the hand upon the disc and the annular peripheral portion of the dispenser. As the ligature is drawn from the dispenser, the reel turns on the boss. Drag is exerted on the ligature by frictional resistance between the reel and the boss, or between the reel and the disc, to prevent the ligature from unreeling too freely.

The boss has a journal portion on which the reel turns,

' and a shoulder at the tip of the boss which protrudes radially *beyond the journal portion. The reel has a central flexible portion formed of a flexible and resilient plastic material. This central portion defines a circular bore having a diameter approximately equal to that of the journal portion of the boss. The central flexible portion of the reel is adapted to flex outwardly and temporarily increase the diameter of the bore to allow the reel to snap over the shoulder and onto the journal portion of the boss. Thus, the reel is held firmly in position on the boss and is prevented from accidental displacement therefrom by the shoulder. In addition, the dispenser may be so de signed that the axial distance between the back edge of the shoulder and the fiat side wall of the disc normally is less than the distance between the front edge of the resilient central portion of the reel and therear-most surface of the reel when the reel and thedisc are unassembled. This means that when the reel and the disc are assembled with the reel in position on the journal portion of the boss, the central portion of the reel is displaced or distorted rearwardly of its normal position in such a way that it presses forwardly against the shoulder and the rear-most surface of the reel presses against the disc, thereby providing frictional drag between the shoulder and the reel on one side and the disc and the reel on the other side of the reel.

Preferably, all of the parts of the dispenser are formed of a flexible and resilient plastic material such as polyethylene or polypropylene. It has been found that such materials, not only provide the desired frictional drag =between the reel and the other parts of the dispenser while allowing the reel to be snapped on the boss with ease, but also allow the reel to be prevented from turning when it is desired to hold the ligature during tieing or cutting merely by pressing the reel against the disc with one finger of the hand holding the dispenser. In addition, these materials are durable, sterilizable, and free from any toxic effect, and may be molded easily to form the various parts of the dispenser of this invention.

Other and further advantages of this invention will be apparent from the following description and claims taken together with the drawings wherein:

FIG. 1 is a schematic view showing a dispenser according to this invention cupped in one of the gloved hands of a surgeon while the free end is held in the other hand in preparation for tieing.

FIG. 2 is a side view, partly in elevation and partly in section, of a dispenser according to one embodiment of this invention.

FIG. 3 is an end view partly in elevation and partly in section taken along the line 33 of FIG. 2 and showing the reel, itself, in elevation.

FIG. 4 is a greatly enlarged view in section showing a portion of the dispenser of FIG. 3 before the reel is snapped onto the boss.

FIG.5 is a View similar to FIG. 4 showing the reel after it has been snapped onto the boss.

Referring to the drawings, there is shown a ligature dispenser 11 according to the preferred embodiment of this invention. This dispenser comprises a reel 12 for holding a ligature 13 wound thereon, a circular supporting are integral andmolded in one piece, and all of the parts of the dispenser are formed of a flexible and resilient plastic material such as polyethylene or polypropylene.

The boss 15 has a journal portion 17 adjacent the disc 14 on which the reel 12 turns whenvthe parts are assembled, and a shoulder 18 in the form of a cylindrical flange at the tip of the boss which protrudes radially beyond the journal portion 17, i.e., the shoulder has a larger'diameter than the journal. This is shown in detail in FIGS.

4 and 5.

The reel 12 has a central flexible and resilient portion 19 which defines a circular hole, or bore, 21, having a diameter approximately equal to that of the journal portion 17 'of-the boss. The central-portion 19 of the reel is 'adapted to flex; outwardly when it is pressed over the shoulder 18 at the tip of the boss 15 to temporarily increase the diameter of the 'bore 21 to allow the reel 12 to pass over the shoulder and snap onto the journal portion 17 thereof. Again, this relationship is shown in detail in FIGS. 4 and 5. The front end of the tip of the boss 15 is formed with an outward taper 22 extending to the perimeter of-the shoulder 18 to facilitate insertion of the boss in the bore of the reel. When the reelis in position onthe journal portion of the boss, it is prevented from accidental displacement therefrom by the shoulder 18 since the diameter of the shoulder is somewhat greater than that of the bore 21 of the central resilient'portion 19 of the reel.

'In the embodiment shown, the central resilient portion 19 of the reel is in the form of a plate or disc of plastic material which extends radially outwardly from the bore 21 to an annular channel extending around the periphery of the reel 12. This channel is formed by an annular rim 25 and flanges 23-and 24 spaced axially from one another and extending radially outwardly from the edges of the rim. The rim 25 connects the flanges to the central resilientportion 19 of the reel and, at the same time, forms thebase of the channel. 'It should be noted, at

this point, that the reel 12 of this embodiment is reversible, i.e., symmetrical and therefore can be assembled together with the supporting disc 14 with either side of the reel toward the disc. Thus, each'of the flanges 23 and 24 possesses a plurality of apertures 26 in the form of slots spaced approximately 60 apart around the periphcry of the channel for holding the free end of the ligature 13 woundon the reel. The slots 26 extend through 'the edges of the reel approximately to the sides of the central'resilient portion 19. Each of the flanges 23 and 24 also possesses a set of three winding openings 27 in "the form of windows spaced 120 apart around the flanges. The windows 27 are arranged in 'pairs, one in each flange, so thatone can see through the reel 12 at each pair of windows. The winding openings27 are useful for windingthe ligature 13 on the reel 12 without tension, as will-be described more fully hereinafter. The

inside surfaces of the flanges 23 and 24 preferably are tapered toward the rim 25 to facilitate winding of the ligature without binding.

As indicated above, the diameter of the bore 21 in the resilient central portion 19 of the reel is approximately equal to that of the journal portion 17 of the boss 15. This provides a tight fit between the reel 12 and the journal 17 when the parts are assembled and allows drag to be exerted on the ligature 13 due to the frictional resistance between-the reel 12 (at the bore) and the journal portion 17 of the boss. Frictional resistance between the reel 12 and the boss-disc combination also may be provided by designing the parts so that the axial distance between the back edge 28 of the shoulder 18 and the disc normally is less than the distance between the fnont edge of the resilient central portion 19 of the reel (at the boss) and the corresponding rear surface of the reel 12 when the reel and the disc are unassem bled. When the reel and the disc are assembled with the parts designed as described above, the central portion 19 of the reel is displaced rear-wardly of its normal position in such a way that it presses forwardly against the shoulder 18 while corresponding surfaces of the reel 12 and the disc 14 press against one another. This provides frictional resistance to the turning of the reel by virtue of the pressure between the shoulder and the reel, on one side, and the disc and the reel, on the other side, of the reel. Either the rear'flange 24 of the reel, or the rear surface of the central portion 19 of the reel (at the boss) may contact the disc, depending upon their dimensions and locations. In order to position the reel 12 properly on the journal portion 17 of the boss the central portion 31 of the disc 14 is displaced forwardly where it joins the boss 15. Thus, the length of the journal portion 17 of the boss is defined by the shoulder 18, at the front end, and the displaced central portion 31 of the disc, at the base of the boss. Normally the journal 17 is only slightly longer than the thickness of the central portion 19 of the reel at the boss, or approximately equal thereto, so thatthe reel 12 does not slide on the boss 15. The above described frictional resistance between the boss-disc combination and the reel can be provided by shortening the length of the journal 17 to cause the back of the central portion 19 of the reel (at the boss) to bear against the displaced portion 31 of the disc, or the rear flange 24 of the channel at the periphery of the reel may be so located that the flange bears against the disc 14; when the central portion 19 of the reelis in position on the journal and pressing against the rear edge 28 of the shoulder 18 at the tip of the boss.

The reel 12 and the boss-disc combination may be assembled simply by pressing the reel 12 on the boss 15 to snap it in position, as described above. Prior to this, the reel is mounted on a set of three Winding prongs, not shown, which normally extend completely through the three pairs of windows 27 or winding openings in the flanges 23 and 24 of the reel. The ligature 13 then is positioned in the channel extending around the periphcry of the reel by winding it tightly over the three prongs which are positioned across the channel at the windows. When the winding of the ligature is completed, the prongs are removed by drawing them through the windows leaving the ligature 13 wound in a coil in the channel without tension; The free, or leading, end 32 of'the ligature 13 is held to prevent the ligature from unwinding simply by positioning it in the nearest slot or aperture 26 in one of the flanges 23 or 24. Next, the reel containing the coil of ligature 13 wound thereon is snapped onto the boss-disc combination with the flange holding the free end 32 of the ligature facing outwardly. The dispenser and ligature may be sterilized prior to packaging, during packaging, or after the package is sealed. In any case, the dispenser is placed in anoutside package of some sort, preferably a sterile envelope,

not shown, which can easily be opened by tearing oft one end of the envelope or stripping it apart. Any one of various sterilizing techniques may be employed. For instance, if it is desired to sterilize the dispenser containing the ligature before or during packaging, the components may be sterilized by ethylene oxide gas in a carboxide autoclave, or if it is desired to sterilize the package and contents after the package has been scaled, electron beam sterilization may be employed.

In use, the unopened package containing the sterile dispenser and ligature is brought to the operating room with the interior of the package arid contents in a sterile condition. The package then is opened by the circulating nurse without touching the contents and the con tents, i.e., the dispenser 11 with the ligature 13 wound thereon is placed on a table in the sterile zone or handed to the sterile nurse.

When the surgeon is ready to begin ligating, the dispenser i1 is handed to him. He cups the dispenser in one of his gloved hands and positions it for use merely by pressing the disc side of the dispenser into the palm of one hand so that he can grip the dispenser by the pressure of his palm against the disc 14 and the annular peripheral portion 16 thereof. in the embodiment shown, the peripheral portion 16 of the disc is in the form of an annulus which extends axially over the periphery of the reel 12 on the disc side of the reel to provide a shield which prevents any substantial pressure from being exerted directly on the channel portion of the reel by the palm of the hand holding the dispenser. The inclined configuration of the peripheral portion 16 of the disc, shown most clearly in FIG. 3 of the drawings, has been found to be particularly advantageous for this purpose. Even though this shield extends axially over the periphery of the reel, it does not block the passage of the ligature 13 from the dispenser as the ligature is unwound because suificient clearance is provided for this purpose between the peripheral portion 16 and the flange 23.

When the desired length of ligature is drawn out, it is held between the fingers of one hand and the fingers of the other, while the dispenser remains cupped in the palm of one hand. Thus, the fingers of the surgeon are completely free to handle the ligature during tieing and cutting. If it is desired to prevent the reel 12 from turning with respect to the disc 14, the surgeon need only press the reel against the disc by the fingers closest to the dispenser. Due to the flexible and resilient nature of the reel, very little pressure is needed to create suflicient friction for this purpose. However, the surgeons fingers may be left completely free for tieing if he presses the ligature into one of the slots 26 in the front flange 23 of the reel. After each tie, the ligature is cut and another tie may be made by drawing the ligature out and working with the free end as described above.

it will be seen that, when the dispenser is resting on the sterile table prior to use, the ligature is completely protected against both mechanical damage and direct contact contamination since it is covered by the parts of the dispenser. As long as the ligature is held in the dispenser, it will remain in unkinked condition and be completely ready for use. During use, that portion of the ligature which is not actually being used remains protected against mechanical damage and direct contamination because it is held and covered by the various parts of the dispenser. The particular length of ligature needed to make a tie is dispensed easily merely by drawing the free end of the ligature 32 from one of the positioning slots 26 and causing the reel 12 to turn on the boss 15. As explained above, this may be done in a Way which leaves the surgeons fingers completely free for the tieing and cutting operations.

Having now described the invention in specific detail and exemplified the manner in which it may be carried into practice, it will be readily apparent to those skilled in the art that innumerable variations, modifications, applications, and extensions of the basic principles involved may be made without departing from its spirit and scope.

The invention claimed is:

1. A ligature dispenser comprising a flat cylindrical reel adapted to carry a length of ligature wound thereon in a plurality of turns, in the form of a coiled ligature, a circular supporting disc at one side of the reel and a centrally located cylindrical boss extending sideways from said disc for supporting said reel, the central portion of said reel defining a bore having an inside diameter approximately equal to the outside diameter of said boss so that the reel may be mounted for rotation on said boss by inserting the boss in said bore, the supporting disc having an annular peripheral shield extending radially beyond the maximum periphery of said reel and axially over the reel and the coiled ligature carried by said reel, whereby the dispenser may be held by cupping it in the palm of one hand so as to press upon the disc and the annular peripheral shield thereof and a length of ligature may be drawn out for dispensing by pulling on the ligature to cause the reel to turn on the boss and unwind the desired length.

2. A ligature dispenser according to claim 1, wherein all of the parts are formed of a flexible and resilient plastic material selected from the group consisting of polyethylene and polypropylene.

3. A ligature dispenser according to claim 2, wherein the reel comprises a pair of annular flanges spaced axially from one another and extending radially toward the periphery of the reel to form an annular channel extending around the reel which is adapted to receive a ligature wound therein, and at least one of said flanges defines a plurality of winding openings through which winding prongs may extend for winding a ligature over said prongs in said channel, whereby said prongs thereafter may be removed from said winding openings to leave said ligature wound in said channel without tension.

4. A ligature dispenser according to claim 1, wherein the reel comprises a pair of annular flanges spaced axially from one another and extending radially toward the periphery of the reel to form an annular channel extending around the reel which is adapted to receive a ligature wound therein, and the flange on the side of the reel 0pposite to said disc possesses a plurality of apertures for holding the end of the ligature wound on said reel.

5. A ligature dispenser according to claim 1, wherein the boss has a cylindrical journal portion for supporting said reel and a shoulder at the tip of the boss, and the said central portion of said reel defines a bore having an inside diameter greater than the outside diameter of said journal portion and less than the diametric dimension of said shoulder so that the central portion of said reel must be snapped over said shoulder to seat the reel on the journal portion, one of said boss and the said central portion of said reel being of a flexible and resilient plastic material capable of deformation to allow the reel to be snapped onto said boss in the aforesaid manner.

References Cited in the file of this patent UNITED STATES PATENTS 376,858 Cone Jan. 24, 1888 2,463,009 Woodland et al. Mar. 1, 1949 2,712,908 Kozminski July 12, 1955 2,855,717 Heil Oct. 14, 1958 3,006,574 Hardy Oct. 31, 1961 FOREIGN PATENTS 215,141 Australia May 19,1958 

1. A LIGATURE DISPENSER COMPRISING A FLAT CYLINDRICAL REEL ADAPTED TO CARRY A LENGTH OF LIGATURE WOUND THEREON IN A PLURALITY OF TURNS, IN THE FORM OF A COILED LIGATURE, A CIRCULAR SUPPORTING DISC AT ONE SIDE OF THE REEL AND A CENTRALLY LOCATED CYLINDRICAL BOSS EXTENDING SIDEWAYS FROM SAID DISC FOR SUPPORTING SAID REEL, THE CENTRAL PORTION OF SAID REEL DEFINING A BORE HAVING AN INSIDE DIAMETER APPROXIMATELY EQUAL TO THE OUTSIDE DIAMETER OF SAID BOSS SO THAT THE REEL MAY BE MOUNTED FOR ROTATION ON SAID BOSS BY INSERTING THE BOSS IN SAID BORE, THE SUPPORTING DISC HAVING AN ANNULAR PERIPHERAL SHIELD EXTENDING RADIALLY BEYOND THE MAXIMUM PERIPHERY OF SAID REEL AND AXIALLY OVER THE REEL AND THE COILED LIGATURE CARRIED BY SAID REEL, WHEREBY THE DISPENSER MAY BE HELD BY CUPPING IT IN THE PALM OF ONE HAND SO AS TO PRESS UPON THE DISC AND THE ANNULAR PERIPHERAL SHIELD THEREOF AND A LENGTH OF LIGATURE MAY BE DRAWN OUT FOR DISPENSING BY PULLING ON THE LIGATURE TO CAUSE THE REEL TO TURN ON THE BOSS AND UNWIND THE DESIRED LENGTH. 